FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer

Dose escalation of NERLYNX therapy demonstrated improved management and prevention of Grade 3 diarrhea

LOS ANGELES, Calif., July 1, 2021 – Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement to the U.S. Prescribing Information for NERLYNX® that incorporates the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL Trial and the new 133 count commercial NERLYNX SKU. The new 133 count SKU, i.e., a bottle containing a four-week supply of 133 tablets, is aligned with the use of NERLYNX dose escalation and designed to better support patient needs. Read complete news release HERE.

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Epizyme Launches EZH2Now Testing Program with Quest Diagnostics for Relapsed or Refractory Follicular Lymphoma Patients

CONTACTS: Jacquie Ross, Investors (650) 358-1054 Mary Lynn Carver, Media (410) 443-1853

For Immediate Release

KITE ANNOUNCES YESCARTA® CAR T-CELL THERAPY IMPROVED EVENT-FREE SURVIVAL BY 60% OVER CHEMOTHERAPY PLUS STEM CELL TRANSPLANT IN SECONDLINE RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA

— Landmark ZUMA-7 Study was Initiated in 2017 as the First Randomized Clinical Trial to Test the Earlier Use of a CAR T-cell Therapy Against Standard of Care —

— Study Met the Primary and Key Secondary Endpoints of Event-Free Survival and Objective Response Rate, Demonstrating a Highly Statistically and Clinically Significant Improvement Compared to Standard of Care —

Santa Monica, Calif., – June 28, 2021 – Kite, a Gilead Company (Nasdaq: GILD), today announced top-line results from the primary analysis of ZUMA-7, a randomized Phase 3 global, multicenter study showing superiority of Yescarta® (axicabtagene ciloleucel) compared to standard of care (SOC) in second-line relapsed or refractory large B-cell lymphoma (LBCL). With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). The study also met the key secondary endpoint of objective response rate (ORR). The interim analysis of overall survival (OS) showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future. Read more HERE.